Drixoral NDA
This article was originally published in The Tan Sheet
Executive Summary
Supplemental NDA 19-453 S/014 covering voluntary labeling changes for acetaminophen approved by FDA March 28. Novartis submitted mock-color labeling for Drixoral Cold & Flu and Allergy Sinus extended release tablets to agency "for revisions to the Drug Facts labeling, including changes to the active ingredients and warnings section"...